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Improving Informed Consent Process for Trauma Patients in the Emergency Department

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01338480
First received: April 18, 2011
Last updated: August 1, 2011
Last verified: April 2010

April 18, 2011
August 1, 2011
April 2010
August 2012   (final data collection date for primary outcome measure)
knowledge score [ Time Frame: immediately and 3 months after the intervention ] [ Designated as safety issue: No ]
The primary outcome, patient understanding of the procedure, risks, benefits, and alternatives, will be determined by quantitative scores on the written examination
Same as current
Complete list of historical versions of study NCT01338480 on ClinicalTrials.gov Archive Site
satisfaction and completion time [ Time Frame: immediately after the intervention ] [ Designated as safety issue: No ]
Secondary outcomes include patient satisfaction with the informed consent process, determined by a five-point ordinal satisfaction scale, and the time to complete the consent process for the surgery.
Same as current
Not Provided
Not Provided
 
Improving Informed Consent Process for Trauma Patients in the Emergency Department
Improving Informed Consent Process for Trauma Patients in the Emergency Department

This study is planning to develop the audiovisual videos and determine whether educational videos are superior to routine discussion for informing trauma patients in emergency department (ED) about risks, benefits, and alternatives to receiving surgery.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Trauma
  • Surgery
Other: video
The videos will be developed and contain information on the procedure, risks, benefits, and alternatives of the surgery.
Experimental: video
The intervention group includes patients who obtain information about the surgery from a video will view at their bedside on a laptop.
Intervention: Other: video
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
Not Provided
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years of age or older
  • scheduled to receive the surgery

Exclusion Criteria:

  • clinically unstable
  • refuse to participate
  • unable to understand the consent process for this study
Both
18 Years and older
No
Contact: Yen-Ko Lin, M.D. +886-7-3121101 ext 7579 yenko@ms16.hinet.net
Taiwan
 
NCT01338480
KMUH-IRB-980361
No
Yen-Ko Lin, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Not Provided
Principal Investigator: Yen-Ko Lin, M.D. Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP